Anesthesia; ReactionNCT03276533
Dexmedetomidine Combined With Lidocaine Infusion Affect Inflammation Cytokines
A study testing Saline, Lidocaine and Dexmedetomidine in people with Anesthesia; Reaction, run by Anqing Municipal Hospital at 1 site in China.
Trial summary
Objective: The present study was to evaluate the effects of dexmedetomidine alone, lidocaine alone and their combined infusion on postoperative inflammation cytokines after Laparoscopic hysterectomy. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Reaction
- What is being tested?
- Saline, Lidocaine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 10 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I and II
- weighted 50 kg-65 kg
- aged 40-65 yr
- elective laparoscopic hysterectomy with general anesthesia
Who cannot join
- a history of allergy to local anesthetics
- severe respiratory, renal or hepatic disease
- preoperative opioids medication
- psychiatric medical history
- Patients with severe hypotension [mean arterial pressure (MAP<60 mmHg)] or bradycardia [heart rate (HR) <40 beats per minute (bpm)], arrhythmia, or urticaria due to lidocaine and dexmedetomidine infusion during the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intravenous Dexmedetomidine, Lidocaine and Their Combination on Postoperative Inflammation Cytokines After Laparoscopic Hysterectomy With General Anesthesia
Objective: The present study was to evaluate the effects of dexmedetomidine alone, lidocaine alone and their combined infusion on postoperative inflammation cytokines after Laparoscopic hysterectomy.
Methods: Investigators enrolled 160 women with American Society of Anesthesiologists (ASA) physical status I and II, aged 40-65 years, and scheduled for elective laparoscopic hysterectomy with general anesthesia from October 2017 to August 2018. The participants were randomly assigned into four groups(n=40 each group): group CON received normal saline infusion, group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion), group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) and group LIDO+DEX received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusions (0.5 µg/kg loading, 0.4 µg/kg/h infusion). The four groups received an IV bolus infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine until abdominal wound closure, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), the end of surgery (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4).
- Conditions
- Anesthesia; Reaction
- Being tested
- Saline, Lidocaine, Dexmedetomidine, Lidocaine plus Dexmedetomidine
- Keywords
- dexmedetomidine; lidocaine; cytokine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Participants in the group CON were received normal saline infusion until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
LidocaineDrug
Participants in the group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion)until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
DexmedetomidineDrug
Participants in the group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) until 30 min before the end of the operation. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
Lidocaine plus DexmedetomidineDrug
Participants in the group LIDO+DEX were received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusion (0.5 μg/kg loading, 0.4 μg/kg/h infusion) until 30 min before the end of the operation, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
| Study group | Role | What they receive |
|---|---|---|
| Intravenous saline, dexmedetomidine and lidocaine | Experimental | Not described Receives: Drug: Saline; Drug: Lidocaine; Drug: Dexmedetomidine; Drug: Lidocaine plus Dexmedetomidine |
| Intravenous saline, dexmedetomidine, lidocaine and combination | Experimental | Not described Receives: Drug: Saline; Drug: Lidocaine; Drug: Dexmedetomidine; Drug: Lidocaine plus Dexmedetomidine |
| Intravenous saline,dexmedetomidine plus lidocaine | Experimental | Not described Receives: Drug: Saline; Drug: Lidocaine; Drug: Dexmedetomidine; Drug: Lidocaine plus Dexmedetomidine |
| Intravenous saline, dexmedetomidine combined with lidocaine | Experimental | Not described Receives: Drug: Saline; Drug: Lidocaine; Drug: Dexmedetomidine; Drug: Lidocaine plus Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6
Interleukin-6 level in serum was measured at the before administration of drugs (T1), Interleukin-6 level in serum was measured at the end of the operation (T2); Interleukin-6 level in serum was measured at the postoperative 2 hour (T3); Interleukin-6 level in serum was measured at the postoperative 24 hour (T4)
Measured: postoperative 24 hours
Tumor necrosis factor-α
Tumor necrosis factor-α level in serum was measured at the before administration of drugs (T1); Tumor necrosis factor-α level in serum was measured at the end of the operation (T2); Tumor necrosis factor-α level in serum was measured at the postoperative 2 hour (T3); Tumor necrosis factor-α level in serum was measured at the postoperative 24 hour (T4)
Measured: postoperative 24 hours
Interleukin-1
Interleukin-1 level in serum was measured at the before administration of drugs (T1); Interleukin-1 level in serum was measured at the end of the operation (T2); Interleukin-1 level in serum was measured at the postoperative 2 hour (T3); Interleukin-1 level in serum was measured at the postoperative 24 hour (T4)
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Nov 2017
- Primary completion6 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anqing Municipal Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Responsible party
- Principal investigator, Xu Siqi, Anqing Municipal Hospital
- Investigators
- Wang shenbing, Study director, Department of Anqing Hospital AnesthesiologyXiao jingbo, Principal investigator, Department of Anqing Hospital Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276533
- Sponsor's protocol ID
- xuzhang2013
- Status last verified
- Mar 2022
- First submitted
- 23 Aug 2017
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu S, Hu S, Ju X, Li Y, Li Q, Wang S. Effects of intravenous lidocaine, dexmedetomidine, and their combination on IL-1, IL-6 and TNF-alpha in patients undergoing laparoscopic hysterectomy: a prospective, randomized controlled trial. BMC Anesthesiol. 2021 Jan 6;21(1):3. doi: 10.1186/s12871-020-01219-z.
PubMed 33407156
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Dexmedetomidine, Lidocaine and Their Combination on Postoperative Inflammation Cytokines After Laparoscopic Hysterectomy With General Anesthesia
- ClinicalTrials.gov ID
- NCT03276533
- Acronym / sponsor ID
- xuzhang2013
- Conditions
- Anesthesia; Reaction
- Keywords
- dexmedetomidine; lidocaine; cytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Anqing Municipal HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: The present study was to evaluate the effects of dexmedetomidine alone, lidocaine alone and their combined infusion on postoperative inflammation cytokines after Laparoscopic hysterectomy.
Methods: Investigators enrolled 160 women with American Society of Anesthesiologists (ASA) physical status I and II, aged 40-65 years, and scheduled for elective laparoscopic hysterectomy with general anesthesia from October 2017 to August 2018. The participants were randomly assigned into four groups(n=40 each group): group CON received normal saline infusion, group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion), group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) and group LIDO+DEX received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusions (0.5 µg/kg loading, 0.4 µg/kg/h infusion). The four groups received an IV bolus infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine until abdominal wound closure, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), the end of surgery (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intravenous saline, dexmedetomidine and lidocaine | Experimental | Drug: Saline, Drug: Lidocaine, Drug: Dexmedetomidine, Drug: Lidocaine plus Dexmedetomidine |
| Intravenous saline, dexmedetomidine, lidocaine and combination | Experimental | Drug: Saline, Drug: Lidocaine, Drug: Dexmedetomidine, Drug: Lidocaine plus Dexmedetomidine |
| Intravenous saline,dexmedetomidine plus lidocaine | Experimental | Drug: Saline, Drug: Lidocaine, Drug: Dexmedetomidine, Drug: Lidocaine plus Dexmedetomidine |
| Intravenous saline, dexmedetomidine combined with lidocaine | Experimental | Drug: Saline, Drug: Lidocaine, Drug: Dexmedetomidine, Drug: Lidocaine plus Dexmedetomidine |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status I and II
- weighted 50 kg-65 kg
- aged 40-65 yr
- elective laparoscopic hysterectomy with general anesthesia
Key exclusion criteria (5 listed)
- a history of allergy to local anesthetics
- severe respiratory, renal or hepatic disease
- preoperative opioids medication
- psychiatric medical history
- Patients with severe hypotension [mean arterial pressure (MAP<60 mmHg)] or bradycardia [heart rate (HR) <40 beats per minute (bpm)], arrhythmia, or urticaria due to lidocaine and dexmedetomidine infusion during the surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineParticipants in the group CON were received normal saline infusion until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4) | Drug | Intravenous saline, dexmedetomidine and lidocaine, Intravenous saline, dexmedetomidine combined with lidocaine, Intravenous saline, dexmedetomidine, lidocaine and combination, Intravenous saline,dexmedetomidine plus lidocaine |
| LidocaineParticipants in the group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion)until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4) | Drug | Intravenous saline, dexmedetomidine and lidocaine, Intravenous saline, dexmedetomidine combined with lidocaine, Intravenous saline, dexmedetomidine, lidocaine and combination, Intravenous saline,dexmedetomidine plus lidocaine |
| DexmedetomidineParticipants in the group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) until 30 min before the end of the operation. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4) | Drug | Intravenous saline, dexmedetomidine and lidocaine, Intravenous saline, dexmedetomidine combined with lidocaine, Intravenous saline, dexmedetomidine, lidocaine and combination, Intravenous saline,dexmedetomidine plus lidocaine |
| Lidocaine plus DexmedetomidineParticipants in the group LIDO+DEX were received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusion (0.5 μg/kg loading, 0.4 μg/kg/h infusion) until 30 min before the end of the operation, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4) | Drug | Intravenous saline, dexmedetomidine and lidocaine, Intravenous saline, dexmedetomidine combined with lidocaine, Intravenous saline, dexmedetomidine, lidocaine and combination, Intravenous saline,dexmedetomidine plus lidocaine |
Primary outcome
Interleukin-6
Time frame: postoperative 24 hours
Interleukin-6 level in serum was measured at the before administration of drugs (T1), Interleukin-6 level in serum was measured at the end of the operation (T2); Interleukin-6 level in serum was measured at the postoperative 2 hour (T3); Interleukin-6 level in serum was measured at the postoperative 24 hour (T4)
Tumor necrosis factor-α
Time frame: postoperative 24 hours
Tumor necrosis factor-α level in serum was measured at the before administration of drugs (T1); Tumor necrosis factor-α level in serum was measured at the end of the operation (T2); Tumor necrosis factor-α level in serum was measured at the postoperative 2 hour (T3); Tumor necrosis factor-α level in serum was measured at the postoperative 24 hour (T4)
Interleukin-1
Time frame: postoperative 24 hours
Interleukin-1 level in serum was measured at the before administration of drugs (T1); Interleukin-1 level in serum was measured at the end of the operation (T2); Interleukin-1 level in serum was measured at the postoperative 2 hour (T3); Interleukin-1 level in serum was measured at the postoperative 24 hour (T4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Derived from this study: PubMed 33407156Xu S, Hu S, Ju X, Li Y, Li Q, Wang S. Effects of intravenous lidocaine, dexmedetomidine, and their combination on IL-1, IL-6 and TNF-alpha in patients undergoing laparoscopic hysterectomy: a prospective, randomized controlled trial. BMC Anesthesiol. 2021 Jan 6;21(1):3. doi: 10.1186/s12871-020-01219-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang shenbing study director
Department of Anqing Hospital Anesthesiology
Xiao jingbo principal investigator
Department of Anqing Hospital Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline, Lidocaine and Dexmedetomidine in people with Anesthesia; Reaction, run by Anqing Municipal Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (time frame: postoperative 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03276533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.